Patent Application
20100010535
This disclosure relates generally to an embolic filter deployment system and a method for deploying an embolic filter from the deployment system.
Human blood vessels often become occluded or blocked by plaque, thrombi, other deposits, or material that reduce the blood carrying capacity of the vessel. Should the blockage occur at a critical place in the circulatory system, serious and permanent injury, and even death, can occur. To prevent this, some form of medical intervention is usually performed when significant occlusion is detected.
Several procedures are now used to open these stenosed or occluded blood vessels in a patient caused by the deposit of plaque or other material on the walls of the blood vessels. Angioplasty, for example, is a widely known procedure wherein an inflatable balloon is introduced into the occluded region. The balloon is inflated, dilating the occlusion, and thereby increasing the intraluminal diameter.
Another procedure is atherectomy. During atherectomy, a catheter is inserted into a narrowed artery to remove the matter occluding or narrowing the artery, i.e., fatty material. The catheter includes a rotating blade or cutter disposed in the tip thereof Also located at the tip are an aperture and a balloon disposed on the opposite side of the catheter tip from the aperture. As the tip is placed in close proximity to the fatty material, the balloon is inflated to force the aperture into contact with the fatty material. When the blade is rotated, portions of the fatty material are shaved off and retained within the interior lumen of the catheter. This process is repeated until a sufficient amount of fatty material is removed and substantially normal blood flow is resumed.
In another procedure, stenosis within arteries and other blood vessels is treated by permanently or temporarily introducing a stent into the stenosed region to open the lumen of the vessel. The stent typically includes a substantially cylindrical tube or mesh sleeve made from such materials as stainless steel or nitinol. The design of the material permits the diameter of the stent to be radially expanded, while still providing sufficient rigidity such that the stent maintains its shape once it has been enlarged to a desired size.
Such percutaneous interventional procedures, i.e., angioplasty, atherectomy, and stenting, can dislodge material from the vessel walls. This dislodged material can enter the bloodstream. Some existing devices and technology use a filter for capturing the dislodged material from the bloodstream.
The present disclosure pertains to an embolic filter deployment apparatus which can be configured to be used in connection with an intravascular device. The apparatus can include a guide wire, a filter element associated with the guide wire, a containment element, and an actuation element, movable between a first position and a second position to release the filter from the containment element. The filter element and the containment element can be regions of a single sheet substantially formed from a single piece of material, or multiple pieces bound together to form a single sheet.
Additionally, an embolic filter can be deployed from a containment element, wherein the filter and containment element are formed from a single piece of material, or multiple pieces bound to form a single sheet. The method includes providing a structure or structures for joining the various parts of the containment element and an actuation element, movable between a first position and a second position such that when the actuation element is in the first position, the joining structures or elements hold the containment element in position about the filter and in the second position, the actuation element allows the joining structures or elements release the containment element thereby deploying the filter.
FIG, 1B illustrates the filter assembly as it is ready for delivery to the vessel to be protected.
The following description should be read with reference to the drawings wherein like reference numerals indicate like elements throughout the several views. The drawings, which are not necessarily to scale, are not intended to limit the scope of the claimed invention. The detailed description and drawings illustrate example embodiments of the claimed invention.
All numbers are herein assumed to be modified by the term “about.” The recitation of numerical ranges by endpoints includes all numbers subsumed within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).
As used in this specification and the appended claims, the singular forms “a”, “an”, and “the” include the plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term “or” is generally employed in its sense including “and/or” unless the content clearly dictates otherwise.
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The material used to form the combined filter sheet 24 may be, for example, laser cut to shape in the same process that cuts holes through which blood cells, but not emboli and other debris, may pass. The same operation also may form apertures or other structures which serve as joining slits or elements that, alone or in combination with an actuating element hold the filter element portion of the unitary filter assembly and containment element portion in a folded or otherwise compact configuration when actuation element 34 is in a first position and which release containment element portion, and thus the filter element 18, when actuation element 34 is in a second position.
The sheet from which the combined filter sheet 24 is formed may be a continuous sheet, a pre-perforated sheet, or a woven mesh. It may be formed of any material which is sufficiently flexible and compatible with bodily fluids such as blood. Examples of suitable materials include polyurethane, polyolefin, polyester, and silicone polymers. Assembly of the combined filter sheet 24, as well as other structures which make up the filter assembly 10, may employ materials and methods such as adhesives, sewing, solvent welding, ultrasonic welding, crimping, and the like.
In some embodiments, the entire sheet from which the filter and the combination filter sheet 24 is formed is perforated. In other embodiments, the fabrication process punches or drills holes through at least the portion of the sheet which will form the filter element 18 in order to provide fluid communication between the interior and exterior of the filter element 18. In some embodiments, holes associated with the filter are formed at the time that combination filter sheet 24 is extracted from the sheet. In other embodiments, holes are provided in a separate step. Similarly, the fabrication of the combined filter sheet may include forming joining slits 32, generally associated with containment element portion 28, from portions of the original sheet as by perforation, or joining slits 32 may be constructed from different materials and/or in a separate operation.
Various modifications and alterations of this invention will become apparent to those skilled in the art without departing from the scope and principles of this disclosure, and it should be understood that this invention is not to be unduly limited to the illustrative disclosure set forth hereinabove. All publications and patents are herein incorporated by reference to the same extent as if each individual publication or patent was specifically and individually indicated to be incorporated by reference.
